Alemtuzumab

Overview

Alemtuzumab is a humanized monoclonal antibody specific to lymphocyte antigens. It is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) that is directed against the 21-28 kD cell surface glycoprotein, CD52. The Campath-1H antibody is an IgG1 kappa with the human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath-1G). Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Alemtuzumab was approved by the FDA in 2001. It is marketed as LEMTRADA for multiple sclerosis (MS) treatment and CAMPTAH for B-cell chronic lymphocytic leukemia (B-CLL). The dose of alemtuzumab used for B-CLL is much higher than that for MS, and also at more frequent dosing.

Background

Indication

用于烷化剂氟达拉滨（fludarabine）治疗失败的B细胞性慢性淋巴细胞白血病患者；亦可用于复发缓解型多发性硬化症治疗。

Associated Conditions

B-Cell Chronic Lymphocytic Leukemia
Kidney Transplant Rejection
Relapsing Remitting Multiple Sclerosis (RRMS)
Secondary Progressive Multiple Sclerosis (SPMS)
Steroid Refractory Acute Graft Versus Host Disease
T-cell Prolymphocytic Leukemia (T-PLL)
Refractory Autoimmune Hemolytic Anemia
Refractory Idiopathic thrombocytopenic purpura

Title	Posted	Study ID	Phase	Status	Sponsor
TMLI and Alemtuzumab for Treatment of Sickle Cell Disease	2022/05/20	NCT05384756	Phase 1	Recruiting	City of Hope Medical Center
Addition of JSP191 (C-kit Antibody) to Nonmyeloablative Hematopoietic Cell Transplantation for Sickle Cell Disease and Beta-Thalassemia	2022/05/03	NCT05357482	Phase 1	Active, not recruiting	National Heart, Lung, and Blood Institute (NHLBI)
Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Trial	2021/07/21	NCT04971005	Phase 2	Terminated	Universitätsklinikum Hamburg-Eppendorf
Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.	2020/11/18	NCT04633967	N/A	Completed	Maritime Neurology
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity	2020/04/09	NCT04339777	Phase 2	Recruiting	National Cancer Institute (NCI)
Reduced Intensity BMT for Immune Dysregulatory and Bone Marrow Failure Syndromes Using Post-Transplant Cyclophosphamide	2020/01/18	NCT04232085	Phase 2	Recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Autologous Transplant Targeted Against Crohn's	2019/11/06	NCT04154735	Phase 2	Withdrawn	Northwestern University
Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment Response	2019/09/09	NCT04082260	N/A	UNKNOWN	University Hospital Muenster
Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation	2019/07/15	NCT04018937	Phase 2	Active, not recruiting	Emory University
Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia	2019/06/18	NCT03989466	Phase 1	Completed	M.D. Anderson Cancer Center

Title

Posted

Study ID

Phase

Status

Sponsor

TMLI and Alemtuzumab for Treatment of Sickle Cell Disease

2022/05/20

NCT05384756

Phase 1

Recruiting

City of Hope Medical Center